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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04643470
Other study ID # BGB-3111-217
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date December 22, 2020
Est. completion date September 2024

Study information

Verified date March 2024
Source BeiGene
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 177
Est. completion date September 2024
Est. primary completion date February 26, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Key Inclusion Criteria: 1. Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria. 2. ISN/RPS 2003 Class III/IV lupus nephritis [Type III(A), III (A+C), IV (A), and IV (A+C)], with or without Class V, as confirmed by a renal biopsy. 3. Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening 4. Has 24-hour urine protein excretion > 1.0 g at screening. Key Exclusion Criteria: Exclusion criteria related to systemic lupus erythematous and other diseases: 1. Glomerulonephritis caused by reasons other than systemic lupus erythematous. 2. Sclerosis in >50% of glomeruli on renal biopsy. 3. Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome. 4. Severe extrarenal SLE, including but not limited to severe pulmonary arterial hypertension, severe myocarditis, severe central nervous system lupus (such as neuropsychiatric SLE, seizures, psychosis, transverse myelitis, central nervous system vasculitis and optic neuritis), etc. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Zanubrutinib
Administered as specified in the treatment arm
Placebo
Placebo to match zanubrutinib

Locations

Country Name City State
China Guangdong General Hospital Guangdong Guangzhou

Sponsors (1)

Lead Sponsor Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants with complete renal response Week 49 Day 1
Secondary Proportion of participants achieving complete renal response Up to Week 73 Day 1
Secondary Proportion of participants achieving partial renal response Up to Week 73 Day 1
Secondary Proportion of participants achieving overall renal response Up to Week 73 Day 1
Secondary Time to first complete renal response The time from the date of randomization to the date of the first complete renal response Up to Week 73 Day 1
Secondary Time to first overall renal response The time from the date of randomization to the date of the first overall renal response Up to Week 73 Day 1
Secondary Change in total Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score SLEDAI-2K score is a systemic lupus erythematosus (SLE) activity index based on the presence of 24 features in 9 organ systems which ranges from 0 - 105, with higher scores indicating more severe features in participants in the past 30 days Baseline to Week 49 Day 1
Secondary Area under plasma concentration time curve (AUC) of zanubrutinib Week 1 Day 1 and Week 5 Day 1
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